thic arthritis in pediatric patients 4 years of age and older. Humira can be used alone or in combination with methotrexate.
Psoriatic Arthritis
Humira is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Humira can be used alone or in combination with non-biologic DMARDs.
Ankylosing Spondylitis
Humira is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Crohn’s Disease
Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Ulcerative Colitis
Humira is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of Humira has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.6)].
Plaque Psoriasis
Humira is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a phyician [see Boxed Warning and Warnings and Precautions (5)].
Humira Dosage and Administration
Humira is administered by subcutaneous injection.
Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The recommended dose of Humira for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with Humira. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosing frequency of Humira to 40 mg every week.
Juvenile Idiopathic Arthritis
The recommended dose of Humira for pediatric patients 4 to 17 years of age with polyarticular juvenile idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with Humira.
Pediatric Patients
(4 to 17 years) Dose
15 kg (33 lbs) to <30 kg (66 lbs) 20 mg every other week
(20 mg Prefilled Syringe)
≥30 kg (66 lbs) 40 mg every other week
(Humira Pen or 40 mg Prefilled Syringe
Limited data are available for Humira treatment in pediatric patients with a weight below 15 kg.
Crohn’s Disease
The recommended Humira dose regimen for adult patients with Crohn’s disease (CD) is 160 mg initially on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 |
